Addiction Research Ethics and the Belmont Principles: Do Drug Users Have a Different Moral Voice?
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1 Addiction Research Ethics and the Belmont Principles: Do Drug Users Have a Different Moral Voice? Celia B. Fisher Marie Ward Doty University Chair Director Center for Ethics Education Director HIV and Drug Abuse Prevention Research Ethics Institute Professor Psychology Fisher@Fordham.edu Fisher, C.B. (2010). Addiction research ethics and the Belmont principles: Do drug users have a different moral voice? Substance Use and Misuse, 45, PMID: Research supported by NIDA #RO1 DA A1
2 Drug Use Research: Vulnerabilities of Hidden Populations Health and economic vulnerabilities Cognitive vulnerabilities Social and legal vulnerabilities
3 Belmont Principles Protection of Human Subjects in Research Beneficence and Nonmaleficence Respect for Persons Justice Nuremberg Code, 1946 Universal Declaration of Human Rights (UN) 1947 Declaration of Helsinki, WHO first issued in 1964 Belmont Report US 1979 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects first issued in 1993
4 Additional Principles Integrity Fidelity and Responsibility American Anthropology Association, 1998 American Medical Association, 2001 American Psychological Association, 2010 American Sociological Association, 1997 Public Health Leadership Society, 2002
5 Foundational Principles Often Conflict (National Commission, 1979) Beneficence & Nonmaleficence Ethnography Fidelity and Responsibility HIV Partner Research Respect Treatment Research Justice
6 Goodness-of-Fit Ethics (Fisher 2002, 2004; Fisher & Goodman, 2009; Fisher & Ragsdale, 2006) Vulnerabilities of everyday life must be distinguished from research vulnerability; Research vulnerability is joint product of participant characteristic and research procedures What special life circumstances may render participants more or less susceptible to research risk? Which aspects of the research design may create or exacerbate research risk? What procedures can be implemented to reduce such risks
7 Ethical Principles Through a Participant Lens Privileged status of principles is contextually based Do established principles reflect how participants view the moral world of research? Lack of understanding over/under-estimation Risks & benefits Personal agency Fair access to research
8 GFE: Co-Learning Fisher, 1999, 2002 Investigator Knowledge base Scientific method Testable hypotheses Ethical procedures available to protect participant rights and welfare Participant Expertise Health priorities Cultural values Fears and hopes about the general or specific scientific enterprise The real world context in which hypotheses will be studied
9 Evidence-Based Research Ethics AIMS OF STUDY Which ethical principles do street drug users apply in their moral justifications for resolving specific types of addiction research ethics dilemmas? Do these precepts correspond to Belmont and other traditional research principles? Do street drug users apply these precepts rigidly or on a caseby-case basis sensitive to the contextual nature of each ethical dilemma?
10 Inclusion Criteria: Recruitment Illegal drug use past 30 days (other than alcohol, marijuana) Previous drug use research participation English proficiency Recruitment: shelters, harm reduction centers, methadone mobile distribution sites
11 THE THE CENTER FOR ETHICS EDUCATION CELIA CELIA B. B. FISHER, PH.D., DIRECTOR Participant Characteristics F O R D H A M (N=90) U N I V E R S I T Y Center for Ethics Education, Director, Celia B. Fisher, Ph.D. Demographics 51% Male Age range: (M = 34.7) 42% PWID 22% MSM 21% Caring for child 21% 55% unemployed 54% lived at a shelter, community housing, boarding home or with a family member 68% < high school education 66% History incarceration Ethnicity 31% Black non-hispanic 34% Hispanic (PR) 31% Non-Hispanic White 1% Other Commonly used drugs cocaine (34%) heroin (26%) crack (47%) Amphetamine (100%) street methadone (14%)
12 Procedure 3 Addiction Research Scenarios Retrospective Responsibilities Scenarios read to participants Mixed method: 4-point Likert-type scale response to scenario question followed by narrative rationale Coding: Inter-rater agreement = 94%, 89%, 96%
13 Principles of Co-Learning Focus Opinions on Scientific Ethics/Values/Morality Purpose of Study: to improve the way drug use and related HIV risk research is conducted by learning what community members think about everyday moral dilemmas and specific ethical challenges faced by researchers.
14 Principles of Co-Learning Define Research Research Defined. A research study is conducted by a researcher when he or she wants to understand why things happen the way they do, how people think and feel about issues, or what kinds of treatments may or may not work. For example, a researcher who wants to understand why people get addicted will ask participants to fill out surveys or interview drug users about their drug use. Or a researcher who wants to test whether a new treatment to reduce drug use works will recruit individuals, who use drugs, to participate in a study to test the treatment.
15 Scenario 1: Hold Ss Drugs For months Dr. Jones conducts street interviews on problems faced by poor female drug users raising young children. including sharing her own parenting stories with participants Just prior to an anticipated police raid, Terry, a female participant asks Dr. Jones to hide her drugs for fear her child will be taken away. Dr. Jones does not know whether or not she should break the law and hide the drugs for Terry. 4-point Likert-type scale: In this situation, how important is it for Dr. Jones to obey the law? Why is it important/not important?
16 Scenario 2: Disclose HIV Status Dr. Alba hangs out with street drug users interviewing them about HIV risk. Through interviews he learns that one participant, John, is intentionally hiding his sero-positive HIV status from and having unprotected sex with another participant, Chris, who Dr. Alba knows to be seronegative Dr. Alba tries to convince John to tell Chris about his HIV, but John refuses and reminds Dr. Alba that during informed consent he promised to keep everything confidential Dr. Alba does not know whether he should tell Chris that John is HIV positive. 4-PointLikert-type question: In this situation, how important is it for Dr. Alba to keep his promise to John? Why is it important/unimportant?
17 Scenario 3: Fire Assistant To test an experimental medication for cocaine addiction Dr. Ross will follow research guidelines that say the best way to know if a medicine really works is to randomly assign half the people the medication and half a sugar pill called a placebo. Mary, one of Dr. Ross s research assistants, volunteers at a clinic for homeless persons who are desperate to quit their cocaine addictions Mary makes an exception to the guidelines by putting all the homeless individuals into the medication group In this situation, how important is it for Dr. Ross to fire Mary for making an exception to the guidelines? Why is it important/not important?
18 Theme 1: Beneficence Investigators should strive to do good and prevent harm Maximize scientific knowledge Protect research participants and others from harm Case 1: Hold Drugs Case 2: Disclose Case 3:Fire Asst I don t care if Dr. Jones is a researcher Terry could lose her kid So she should try to help Terry. [Hiding the drug] would perpetuate a risky situation for the child without necessarily helping Terry. Chris could die then [Dr. Alba] will never be able to live with that. Dr. Alba should tell Chris because that is only the right thing to do, That goes beyond the duties of a researcher s promise to keep confidentiality This would violate the integrity of the study and would not necessarily help the addicts since the medicine s effects are yet unproven. Dr. Ross should make an exception because in this case [Mary] is not just breaking the rules, she is trying to help those people.
19 Theme 2: Respect Participants Are responsible for the choices that they make Have the right to knowledge that will affect their safety or Have a right to privacy. Case 1: Hold Drugs If Terry was so concerned about her kid, she wouldn t be doing drugs and hiding from the cops in the 1 st place if you ask me. [Terry] is grown and [should] know.the consequences. Case 2: Disclose HIV John is a grown adult who can let Chris know if he wants. So no [Dr. Alba] should not tell Chris. If Chris had some sense, he would have done some homework of his own and found out for himself. It is not Dr. Alba s job. John has a right to his privacy. If your going to do something that will hurt people s lives, confidentiality does not apply anymore.
20 Theme 3: Justice Fairness requires investigators Ensure equal research opportunity Eliminate bias Make up for historic and current health disparities. Case 3: Fire Assistant Everyone should be treated the same which is why the guidelines were that way. When you make exceptions like that you are not giving everyone an equal chance. By firing Mary Dr. Ross did the right thing because he is saying that he does not support preferential treatment. Because nobody ever does anything for people that are homeless. They deserve exceptions.
21 Theme 4: Relationality Researchers and participants are in relationships that obligate investigators to: maintain participant trust honor the reciprocity of relationships where both get and give. Case 1: Hide the Drugs Just because she is a researcher doesn t mean she stops being a friend Case 2: Disclose HIV John trusted him with something personal, so he should not let him down I feel. How can you trust a researcher if the researcher is going around hiding drugs in their bags? You gotta help the person that s helping her get the data for her research. Because when you agree to participate in a study, you trust the researcher with something very personal. So it is all about trust.
22 Theme 5: Professional Obligations Investigators must serve as a model of right conduct; maintain professional-personal boundaries with participants; preserve the good reputation of the profession; ensure the good conduct of other members of the profession. Case 1: Hide Drugs Case 2: Disclose HIV Case 3: Fire Asst. Dr. Jones should just do her job and not get involved That s getting too personal with your subjects and feels wrong. All that is not Dr. Alba s business if you ask me. He should just stay out of it and not get involved. Informing Chris is not his responsibility. [Mary] should have checked with [Dr. Ross] first. How can she take the decision into her own hands like that? She deserves [to be fired]. [Dr. Jones] should set an example for Terry, not the other way around. If Dr. Jones gets busted then the research organization she works for ends up looking bad too. People need to know boundaries especially when it comes to work. Otherwise they do not learn. if she gets away with it, next time another one of his staff will. So it is important to set examples.
23 Theme 6: Rules Rules have intrinsic moral value--investigators are morally obligated to obey the law, adhere to informed consent agreements with participants, follow research guidelines. Case 1: Hide Drugs Case 2: Disclose HIV Case 3: Fire Asst. You should obey the law no matter what it is. It is what keeps society going. If you promise me to keep my info safe, then you should not go back on it. Everybody should follow rules because otherwise there will be no order. So yes, [Mary] should be punished for that. As a human being [Dr. Jones] should help out Terry, but since she is at a job she should obey the law. As a researcher, Dr. Alba has a responsibility to both Chris and John. But because he promised John he should keep that end of his professional obligation. Dr. Ross should have considered that Mary was trying to help, but since she did break the rules she should be fired I feel.
24 Theme 7: Pragmatic Self-Interest The moral priority in a given situation is to maximize the researcher s own needs and minimize negative consequences to the self. Case 1: Hide Drugs Case 2: Disclose HIV Case 3: Fire Asst. I don t think that [Dr. Jones] should break the law.that would end up with her in jail. [Dr. Alba] has to follow the rules because he could lose his license What if they, the people who gave him the money for the study come after Dr. Ross? So he is doing the right thing he is protecting his job.
25 Do Drug Users Apply Principles Contextually? Rankings Case 1: Hide Drugs Case 2: Disclose HIV Case 3: Fire Asst. Beneficence 26% Rules 26% Professional Obligations 26% Pragmatic Self-Interest 22% Beneficence 24% Rules 22% Professional Obligations 20% Relationality 18% Beneficence 20% Justice 20% CBFisher
26 Drug Users as Moral Agents Drug users have the ability and willingness to grapple with complex dimensions of morality They share with investigators an appreciation for foundational moral principles guiding research These include the Belmont principles as well as principles reflecting a valuing of professional obligation and relationality Their application of these principles are contextually sensitive
27 Individual and Professional Responsibility Drug users see themselves as responsible for the consequences of their actions They hold researchers to a higher standard of moral excellence Uphold professional standards Act as role models Avoid blurring of roles Treat participants fairly
28 Relationships of Trust and Care Street drug users value participant-scientist relationships based on trust Believe some moral ideals supersede professional obligations, including protecting children, saving a life, and helping the needy
29 Research Ethics Through a Participant Lens Research is a moral endeavor Participant perspectives are essential to inform but cannot dictate ethical decisions Participant perspectives lends moral authority to ethical decisions
30 Questions/further discussion
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